Early Co-Administration of Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock

NCT07418541 | Not Yet Recruiting

• 2 other identifiers: 344/KEPK/USU/2025No.344/KEPK/USU/2025
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality. This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol. Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.

Conditions

Septic Shock; Acute Kidney Injury

Keywords

Sepsis; Fluid Resuscitation; Norepinephrine; Hemodynamic Stabilization; Acute Kidney Injury Prevention

Outcome Measures

Primary Outcomes (1)

• Occurrence of Acute Kidney Injury

  Acute kidney injury is assessed based on changes in renal function parameters following early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock.

  Within 48 hours after intervention

Secondary Outcomes (1)

• Change in Mean Arterial Pressure

  Within 30 minutes after intervention

Study Arms (1)

Early Fluid Resuscitation Plus Norepinephrine

EXPERIMENTAL

Participants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention.

Drug: Norepinephrine; Other: Crystalloid Fluid Resuscitation

Interventions

Norepinephrine DRUG

Norepinephrine is administered as an intravenous infusion initiated early in patients with septic shock at an initial dose of approximately 0.05 µg/kg/min. The dose is titrated based on hemodynamic response to achieve and maintain adequate mean arterial pressure in accordance with standard clinical practice.

Also known as: Noradrenaline

Early Fluid Resuscitation Plus Norepinephrine

Crystalloid Fluid Resuscitation OTHER

Participants receive intravenous crystalloid fluid resuscitation at a total dose of 30 mL per kilogram of body weight as part of early management of septic shock. Fluid administration is provided according to institutional protocols and patient clinical condition.

Also known as: Intravenous Crystalloid Fluids

Early Fluid Resuscitation Plus Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older.
• Diagnosed with septic shock based on clinical criteria.
• Require fluid resuscitation and vasopressor support.
• Admitted to the intensive care unit or emergency department.
• Have complete baseline clinical and hemodynamic data.

You may not qualify if:

• Patients with end-stage renal disease or receiving chronic dialysis.
• Known pregnancy.
• History of severe chronic kidney disease.
• Patients with limitations of care or do-not-resuscitate orders.
• Incomplete clinical data for outcome assessment.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Related Publications (4)

• Mehta Y, Paul R, Rabbani R, Acharya SP, Withanaarachchi UK. Sepsis Management in Southeast Asia: A Review and Clinical Experience. Journal of Clinical Medicine. 2022;11(13):3635-45. DOI: 10.3390/jcm11133635

  BACKGROUND

• Monnet X, Lai C, Ospina-Tascon G, De Backer D. Evidence for a personalized early start of norepinephrine in septic shock. Critical Care. 2023;27(1):1-4. DOI: 10.1186/s13054-023-04593-5

  BACKGROUND

• Ospina-Tascón GA, Hernandez G, Alvarez I, Calderón-Tapia LE, Manzano-Nunez R, Sánchez-Ortiz AI, et al. Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis. Crit Care. 2020;14(24):52. DOI: 10.1186/s13054-020-2756-3

  BACKGROUND

• Permpikul C, Tongyoo S, Viarasilpa T, Trainarongsakul T, Chakorn T US. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019;199(9):1097-105. DOI: 10.1164/rccm.201806-1034OC

  BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury; Sepsis

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Irfan Julio Nasution, MD

  Universitas Sumatera Utara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irfan Julio Nasution, MD

CONTACT

+6285296993309; irfanjulionst@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Department of Anesthesiology and Intensive Therapy, Universitas Sumatera Utara

Model Details: This study uses a single-group pretest-posttest design in which all participants receive early co-administration of crystalloid fluid resuscitation and norepinephrine. Hemodynamic and renal parameters are assessed before and after the intervention.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share